ANKASCIN 568-P red yeast rice for lowering HbA1c and blood sugar

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled trial lasting 24 weeks with about 80 participants. Subjects are assigned to take two capsules daily of ANKASCIN 568-P (440 mg per capsule) or matching placebo, with biochemical blood tests at baseline and at weeks 4, 12, and 24. Investigators will track HbA1c, fasting glucose, blood lipids, blood pressure, body measurements, and monitor liver, kidney, and thyroid function. The protocol includes screening, a treatment period, and a discontinuation follow-up to observe longer-term changes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men or non-pregnant women over 20 years old (women of childbearing age are not allowed to become pregnant or breastfeed during the study) adults who are sane and able to communicate.
2. 18≦BMI≦35.
3. Blood routine examination (CBC; Complete blood count): the mean corpuscular volume MCV should not be less than 70 fL.
4. Blood glucose level measurement meets any of the following conditions:

(1) The fasting blood sugar is between 100∼125 mg/dL, and the doctor judges that there is no need to use hypoglycemic drugs for the time being.

(2) Or the glycosylated hemoglobin is between 5.7∼6.4%, and the doctor judges that the use of hypoglycemic drugs is not needed for the time being.

(3) Diabetic patients who have no willingness to take medicine and have not taken hypoglycemic drugs in the past month.

5\. Those without other serious diseases (cancer, heart failure, myocardial infarction, liver cirrhosis, moderate to severe liver and kidney dysfunction, stroke, etc.).

6\. Hypoglycemic drugs are not allowed to be used during the trial. If the condition changes and the use of hypoglycemic drugs is required, the trial must be withdrawn.

7\. During the test period, the daily routine and eating habits should be maintained without deliberately changing them.

Exclusion Criteria:

1. Blood pressure: systolic blood pressure ≧ 200 mmHg or diastolic blood pressure ≧ 140 mmHg.
2. Moderate or severe liver and kidney dysfunction (generally refers to serum aminopyruvate converting enzyme (SGPT) and serum glutamate phenylacetate transaminase (SGOT) are more than 3 times higher than the upper limit of normal value or have been diagnosed Liver cirrhosis, or glomerular filtration rate eGFR≦30 ml/min/1.73m2).
3. Pregnant or lactating women.
4. Diabetic patients taking hypoglycemic drugs or insulin injections.
5. Those who take traditional Chinese medicine mainly red yeast rice.
6. Have undergone surgery within one month.
7. Combined with serious diseases such as heart, liver, kidney and hematopoietic system, mentally ill patients who do not meet the inclusion criteria, who do not eat the test samples according to the regulations, so that the efficacy cannot be judged or the incomplete data affect the judgment of efficacy or safety.

Where it's running

• Tri-Service General Hospital, National Defense Medical Center, Taipei city,
  Taipei, Taiwan Recruiting

Study contacts

• Principal investigator: WEN-HUI FANG, Ph. D. — Chief of Family medicine department
• Study coordinator: Sean Lin
• Email: sean.lin@sunway.cc
• Phone: 02-27929568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.